Kornimate/medical-research-clean huggingface dataset:
pre-operative stereotactic ablative body radiotherapy followed by immediate surgery for pancreatic cancer

Conditions: Cancer of Pancreas

Summary: a window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.

this is a single-centre, prospective, non-randomised feasibility study. this study will assess whether sabr can safely be given immediately prior to whipple's resection by assessing the rate of post-operative complications.

Eligibility criteria:
inclusion criteria stage 1: * have given written informed consent to participate in stage 1 * be aged 16 years or over at the time of signing the informed consent form * presence of a hypodense pancreatic mass on contrast enhanced ct scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (mdt) * have not had pre-operative systemic therapy or radiotherapy inclusion criteria stage 2: * have participated in stage 1 of the study * have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma or radiological evidence of pancreatic head mass with supportive cytological or histological findings. * be scheduled to undergo pancreatico-duodenectomy (whipple's) resection. * written informed consent to participate in stage 2 * aged 16 years or over at the time of signing informed consent * have not had pre-operative systemic therapy or radiotherapy * ecog performance status 0-1 * adequate renal function: gfr ≥ 60 exclusion criteria: * any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk * women who are known to be pregnant * previous abdominal radiotherapy * women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period
the effect of mirror therapy in patients with frozen shoulder

Conditions: Pain; Frozen Shoulder

Summary: the aim of this study compares mirror therapy and visual feedback treatment with the control group in frozen shoulder patients.

thirty-six individuals divided three groups as mirror therapy, visual feedback, and control groups were included in the study for 15 sessions of treatment. all individuals received basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack, stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises. the mirror group bilateral exercised with an affected arm behind the mirror; visual feedback group bilateral exercised by seeing both arms in the mirror; control group bilateral exercised without a mirror for 10 minutes after every session. pain severity was evaluated with the "visual analogue scale (vas)", rom and proprioception were measured with a universal goniometer, and functional status was evaluated with "shoulder pain and disability index (spadi)" and "modified constant score". evaluations were made before, day after the treatment and 4 weeks after the treatment by the same researcher. data analysis was performed with spss.23.

Eligibility criteria:
inclusion criteria: * individuals who were diagnosed with "unilateral frozen shoulder" by the specialist; * normal radiological imaging; * aged between 18-75 years old; * symptoms persist for 2-12 months. exclusion criteria: * if patients had following comorbidities: rotator cuff injury, cervical radiculopathy, romatological diseases, neurological diseases, fracture, tumour, congenital deformities, dislocation or sublocation, surgery in the shoulder, uncontrolled hypertension or diabetes mellitus; * pregnancy; * patients who had previously received physical therapy; * patients having problems in the perception of tests and exercises were excluded from this study

Keywords: frozen shoulder visual feedback proprioception pain insensitivity shoulder pain
influence of walking pilgrimage on changes in body composition, biochemical parameters, circulatory and respiratory efficiency and foot biomechanics in healthy women and men of all ages.

Conditions: Cardiovascular Diseases; Health Behavior; Foot Injuries and Disorders; Skin Condition

Summary: the aim of the study is to assess the health habits and changes in body composition and exercise capacity as well as blood biochemical parameters of people participating in 14-21-day walking pilgrimages. this type of physical activity can be classified as long-term and multi-stage hiking tours. among the people participating in the pilgrimage, a significant part of the population are people aged\> 50 years. moderate physical activity is an important pro-health element, however, it has not been determined yet how long and accumulated activity may affect the health of pilgrims. suddenly taking up activity and the challenge of walking several hundred kilometres may be a heavy burden for the body, and its effects may have a negative impact on the body. the evaluation of the processes taking place in the body under the influence of this type of physical activity, motivated by religious goals, will expand the scope of knowledge about safety as well as health indications and contraindications for this type of activity. it will also allow identifying adaptive changes and their effects


Eligibility criteria:
inclusion criteria: women and men aged 18-65 bmi (body mass index) at the level of 18-39 exclusion criteria: chronic diseases musculoskeletal injuries mental disorders surgery or hospitalization in the last year before the start of the study pregnancy
cardiac rehabilitation and ongoing physical activity during covid-19

Conditions: Cardiac Rehabilitation

Summary: the current coronavirus disease 2019 (covid-19) pandemic has resulted in extraordinary public health orders of social distancing and self-isolation, leading to widespread disruption and discontinuation of cardiac rehabilitation programmes and other social opportunities for cardiovascular disease (cvd) patients to exercise. in austria, the government initiated drastic public health measures (national lockdown) on march 16, 2020, leading to closure of all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation to patients with urgent medical indications only. this study aims to explore the impact of covid-19-related national lockdown and public health restrictions on cardiac rehabilitation patients, with respect to maintenance of physical activity for secondary cvd prevention. the study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (quant-qual) design: 1. what was the impact of the covid-19-related lockdown on patients' physical activity and physical fitness levels? (quant stage) 2. what was the patient experience of the closure of group-based cardiac rehabilitation training due to covid-19 public health restrictions? (qual stage) 3. which insights and learning points may be drawn from patients' experiences during covid-19 public health restrictions with respect to the provision of home-based digital support for physical activity? (qual stage) the study will recruit a cohort of up to 40 cardiac rehabilitation patients from one outpatient cardiac rehabilitation centre in salzburg, austria, whose rehabilitation programme was interrupted by covid-19 public health orders, including "lockdown". patients will undergo re-assessment of physical fitness in cycle ergometry test and re-assessment of cardiovascular risk profile. this will be compared with patients' most recent available test results from before the covid-19 lockdown (i.e. prior to mid-march 2020) from patient records. additionally, patients will take part in a semi-structured qualitative interview in which they will be invited to reflect on their personal experiences during the covid-19 lockdown and thereafter.


Eligibility criteria:
inclusion criteria: * adults (18 years and over) * cardiovascular disease (cvd) * currently enrolled in outpatient cardiac rehabilitation training at the study site * informed consent exclusion criteria: * contraindications for cardiopulmonary exercise testing * pathologies limiting exercise performance * pregnancy or breastfeeding * limited german language

Keywords: covid-19 exercise tolerance physical activity qualitative interview secondary prevention social distancing
empagliflozin in heart failure with reduced ejection fraction and end stage renal disease

Conditions: Heart Failure with Reduced Ejection Fraction; End Stage Renal Disease on Dialysis

Summary: in patients with esrd, up to 20% of patients suffer from hfref, leading to significant cv morbidity and mortality. several drug classes that provide survival benefits for patients with hfref, including sglt2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. as the primary target of sglt2i is expressed mostly in the kidneys, the efficacy of sglt2i in patients with esrd may be limited. on the other hand, patients with esrd are at higher risks of experiencing cardiovascular events and may still benefit from treatment. several mechanistic studies have demonstrated direct actions of sglt2i on the myocardium, thus it is possible that the benefits of sglt2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/esrd were similar to those in subjects with normal renal function. the use of empagliflozin in patients with esrd seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.


Eligibility criteria:
inclusion criteria: * age ≥20 years old * esrd under chronic, maintenance hemodialysis with stable dry weight for the past 6 months * documented left ventricular ejection fraction \<50% by any imaging modality within 1 month of screening exclusion criteria: * age \<20 years old * ongoing pregnancy * nyha class iv heart failure * any hospitalization for heart failure within the past month * ongoing acute urinary tract infection at the time of screening * known acute genital infection * severe peripheral artery disease (rutherford category 4-6) * acute coronary syndrome, stroke or transient ischemic attack within the past month * recent initiation of chronic maintenance hemodialysis within 6 months * adjustment of dry weight with changes greater than 5% of body weight within the past month * documented left ventricular ejection fraction ≥50% by any imaging modality within 1 month of screening * refused informed consent

Keywords: end stage renal disease sodium-glucose co-transporter 2 inhibitors, heart failure with reduced ejection fraction empagliflozin left ventricular mass
improving communication and adherence in black breast cancer survivors (sisters informing sisters)

Conditions: Breast Cancer

Summary: the purpose of this study is to test an evidence-based intervention designed to increase adherence to systemic therapy in black women compared to enhanced usual care.

black women continue to experience worse breast cancer outcomes, which may be due to inadequate adherence to systemic therapies that can be improved via patient-centered communication. we developed and piloted the sisters informing sisterssm (sis) intervention (survivor-led skill-building sessions and culturally tailored materials to activate black breast cancer survivors in their medical encounters) and obtained promising findings. this project will compare in a two-arm rct the impact of sis vs. enhanced usual care (treatment recommendation summary form) on patient-centered communication and systemic treatment adherence; sis tools may be integrated within existing clinical and support services.

Eligibility criteria:
inclusion criteria: * self-identify as black * newly diagnosed (\~4 weeks post-definitive surgery and prior to initiation of adjuvant chemotherapy or endocrine therapy) patients (stage i-iii) * eligible for chemotherapy or endocrine therapy according to nccn guidelines, but have not initiated systemic therapy * ability to read and speak english * ability to provide meaningful consent as determined by trained study personnel and/or a member of the patient's care team * no prior cancer treatment (other than skin cancer) in the two years preceding enrollment * physicians must be a license doctor of study patient(s) * ability to speak english

Keywords: breast cancer black women breast cancer survivor
a study of the safety and efficacy of ag-013,958 in subjects with subfoveal choroidal neovascularization associated with age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: ag-013,958 is being studied to treat patients with age-related macular degeneration. a total of 144 subjects may be enrolled in the trial. subjects will be male or female at least 55 years of age with "wet" age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * male and/or female subjects \>=55 years of age * subfoveal choroidal neovascularization complicating age-related macular degeneration * subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent in accordance with institutional and regulatory guidelines exclusion criteria: * other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year
uab 0718 - phase ii trial to assess target oral therapy as adjuvant chemoprevention in high-risk head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. this study will also determine what effects, good and/or bad, this drug has on the participants.

an investigator-initiated phase ii clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma 2. recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. recurrent neck metastasis with unknown primary is allowed 3. prior radiation therapy for head and neck cancer 4. disease must be considered surgically resectable or candidate for curative reirradiation 5. adequate diagnostic workup 6. zubrod performance status 0-2 7. life expectancy 12 weeks 8. age 19, 9. adequate laboratory data. exclusion criteria: 1. prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (prior non-melanomatous skin cancer and previous carcinoma in situ are permissible) 2. patients who are pregnant or lactating 3. psychological condition that renders the patient unable to understand the informed consent 4. any situation or condition that will interfere with adherence to study activities.

Keywords: resectable, recurrent head and neck cancer
cisplatin and radiation therapy in treating patients with stage iv cancer of the head and neck

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage iv cancer of the head and neck.

objectives: i. determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. ii. determine the partial and complete response rate of cisplatin chemoradiation. iii. determine the incidence of adverse events using cisplatin chemoradiation therapy. iv. determine the rate of disease-free survival and overall survival in these patients. v. determine the incidence and pattern of recurrence in these patients. vi. document quality of life measured by disease-specific instruments in these patients. outline: all patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. one course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. radiotherapy is given 5 days a week for 7 weeks. this weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure. projected accrual: 60 patients will be enrolled.

Eligibility criteria:
disease characteristics: histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx no distant metastatic disease no previous or concurrent head and neck primaries no lip, nasopharynx, or salivary gland lesions no recurrent tumors stage iv disease comprised of t4 no-3 lesions patient characteristics: age: 18 and over performance status: karnofsky greater than 60 life expectancy: not specified hematopoietic: anc greater than 2,000 platelet count greater than 100,000 hepatic: not specified renal: creatinine clearance greater than 50 ml/min cardiovascular: not specified other: not pregnant or nursing no adverse medical illnesses no imaging studies performed greater than one month preregistration no laboratory studies greater than 2 weeks preregistration no other malignancies, except for basal or squamous cell of the skin, within the past 5 years prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy to the head and neck surgery: no prior surgery to study site other than a biopsy other: protocol treatment must begin within 8 weeks of biopsy

Keywords: stage iv squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the larynx
use of 3m cavilon advanced skin protectant in the management of damaged skin around an ostomy, drain or fistula

Conditions: Ostomy

Summary: the objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3m™ cavilon™ advanced skin protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula.

this is a pilot study evaluating the product, 3m™ cavilon™ advanced skin protectant, for the management of skin around an ostomy, drain and/or fistula. all subjects will receive the product for up to 14 days. the primary site must have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone). secondary sites can have red skin with or without breakdown. product will be applied twice/week or more frequently if additional applications are needed due to leakage, skin irritation or standard of care. skin assessments (including photography) will be completed at baseline and at all follow-up visits.

Eligibility criteria:
inclusion criteria: 1. is the subject 18 years of age or older? 2. does the subject have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone) at the primary site of an ostomy, drain and/or fistula? 3. is the subject willing to have photographs taken of their skin and permit use of photographs in potential publication? 4. is the subject willing to release rights to 3m for the use of the photos? 5. is there a reasonable expectation that the subject will be in the hospital or available for follow-up visits during the 14 day study period? 6. has the subject signed an institutional review board-approved informed consent/assent document and authorized the use and disclosure of protected health information? exclusion criteria: 1. if female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit? 2. does the subject have a known allergy to acrylates or cyanoacrylates? 3. does the subject have a preexisting skin disease on the areas affected that may make skin assessments for this study difficult? 4. does the skin area affected require treatment with a concomitant medication or product? 5. has the subject received antifungal powders in the area affected within 24 hours prior to enrollment? 6. has the subject received cyanoacrylate based skin protectant (such as marathon) within 72 hours prior to enrollment? 7. does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study? 8. has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit?
study of the pharmacokinetics and safety of carfilzomib in patients with multiple myeloma and renal disease

Conditions: Relapsed Multiple Myeloma; End-stage Renal Disease

Summary: the purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. this study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

specifically, the purpose of this study is to assess the influence of end-stage renal disease (esrd) on area under the curve (both area under the curve, from time 0 to the last concentration measured \[auc0-last\] and area under the curve, from time 0 extrapolated to infinity \[auc0-inf\]) of carfilzomib 56 mg/m² at cycle 2 day 1 (c2d1) in patients with relapsed multiple myeloma.

Eligibility criteria:
key inclusion criteria: 1. relapsed multiple myeloma 2. evaluable disease (serum protein electrophoresis \[spep\]/urine protein electrophoresis \[upep\]/serum free light chain \[sflc\] criteria) 3. received at least 1 prior treatment regimen or line of therapy for multiple myeloma 4. end-stage renal disease (esrd) on hemodialysis or crcl ≥ 75 ml/min 5. eastern cooperative oncology group (ecog) performance status 0 - 2 6. adequate organ and bone marrow function 7. active congestive heart failure (new york heart association \[nyha\] class iii to iv), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment key exclusion criteria: 1. immunoglobulin m (igm) multiple myeloma 2. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. waldenström macroglobulinemia 4. active congestive heart failure (nyha class iii-iv) ischemia, conduction abnormalities 5. known human immunodeficiency virus (hiv), recent hepatitis b virus (hbv), hepatitis c virus (hcv) 6. myelodysplastic syndrome 7. contraindication to test article, constituents, or required concomitant medications 8. other investigational drugs